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Influence of Analgesia and Neuromuscular Block on Abdominal Distension and Operating Conditions Laparoscopic Operations

Primary Purpose

Neuromuscular Blockade

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
measuring tape
neuromuscular block
Surgical rating score
Sponsored by
Kreiskrankenhaus Dormagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromuscular Blockade

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • laparoscopic gynecologic surgery
  • American Society of Anesthesiologists Physical Status ASA 1-2

Exclusion Criteria:

  • anticipated difficult airway
  • increased risk for pulmonary aspiration
  • acute infection
  • pregnancy
  • impaired liver- oder kidney function
  • neuromuscular disease
  • chronic intake of drugs known to influence neuromuscular blockade

Sites / Locations

  • Kreiskrankenhaus Dormagen

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

abdominal wall length

Arm Description

Measurement of abdominal wall length during neuromuscular block with a measuring tape

Outcomes

Primary Outcome Measures

change in abdominal wall length (cm) during time course of the block
Changes in abdominal wall length are measured during the time course of the neuromuscular block every 15 min.

Secondary Outcome Measures

Change of surgical Rating scale (SRS) scores during neuromuscular block
assessment of operating conditions by means of a standardized score: surgical rating score (Martini et al. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs. deep neuromuscular block. Br J Anaesth 2014; 112: 498-505: extremely poor conditions poor conditions acceptable conditions good conditions optimal conditions The surgical rating score is assessed every 15 min together with abdominal wall length and depth of neuromuscular block
changes of abdominal distension or surgical Rating score (SRS) induced by additional analgesics, sedatives or neuromuscular blocking agents
If a bolus of an analgesic, sedative or neuromuscular blocking agent is required because of inadequate anesthesia during the operation, all measurements mentioned above are performed immediately after the injection of the drug in order to assess the effect of the bolus injection.

Full Information

First Posted
April 12, 2018
Last Updated
August 16, 2022
Sponsor
Kreiskrankenhaus Dormagen
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1. Study Identification

Unique Protocol Identification Number
NCT03605628
Brief Title
Influence of Analgesia and Neuromuscular Block on Abdominal Distension and Operating Conditions Laparoscopic Operations
Official Title
Influence of Analgesia and Neuromuscular Block on Abdominal Distension and Operating Conditions During Gynecologic Laparoscopic Operations
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kreiskrankenhaus Dormagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Neuromuscular block improves operation conditions during laparoscopic surgery. In this study, a new measurement tool is assessed: the degree of abdominal distension during the time course of the neuromuscular block is measured and compared with a standardized score (surgical rating score).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Blockade

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Assessment of the quality of operation conditions by the obstretic surgeon without information with regard to the actual depth of the neuromuscular block or the drugs administrated for improvement of the block.
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
abdominal wall length
Arm Type
Other
Arm Description
Measurement of abdominal wall length during neuromuscular block with a measuring tape
Intervention Type
Other
Intervention Name(s)
measuring tape
Intervention Description
measurement of change in abdominal wall length [cm] during neuromuscular block with a measuring tape.
Intervention Type
Other
Intervention Name(s)
neuromuscular block
Intervention Description
Measurement of the time course of the neuromuscular block: neuromuscular transmission is measured by assessment of the post tetanic count and the train of four ratio using acceleromyography (TOF Watch SX™, Essex Pharma GmbH, Munich, Germany) at the right adductor pollicis muscle with transcutaneous Ag/AgCl electrodes (electrocardiogram electrodes; Ambu Inc., MD 21060 USA);
Intervention Type
Other
Intervention Name(s)
Surgical rating score
Intervention Description
assessment of operating conditions by means of a standardized score: surgical rating score: extremely poor conditions poor conditions acceptable conditions good conditions optimal conditions
Primary Outcome Measure Information:
Title
change in abdominal wall length (cm) during time course of the block
Description
Changes in abdominal wall length are measured during the time course of the neuromuscular block every 15 min.
Time Frame
during operation
Secondary Outcome Measure Information:
Title
Change of surgical Rating scale (SRS) scores during neuromuscular block
Description
assessment of operating conditions by means of a standardized score: surgical rating score (Martini et al. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs. deep neuromuscular block. Br J Anaesth 2014; 112: 498-505: extremely poor conditions poor conditions acceptable conditions good conditions optimal conditions The surgical rating score is assessed every 15 min together with abdominal wall length and depth of neuromuscular block
Time Frame
during operation
Title
changes of abdominal distension or surgical Rating score (SRS) induced by additional analgesics, sedatives or neuromuscular blocking agents
Description
If a bolus of an analgesic, sedative or neuromuscular blocking agent is required because of inadequate anesthesia during the operation, all measurements mentioned above are performed immediately after the injection of the drug in order to assess the effect of the bolus injection.
Time Frame
during operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: laparoscopic gynecologic surgery American Society of Anesthesiologists Physical Status ASA 1-2 Exclusion Criteria: anticipated difficult airway increased risk for pulmonary aspiration acute infection pregnancy impaired liver- oder kidney function neuromuscular disease chronic intake of drugs known to influence neuromuscular blockade
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Soltesz, MD
Organizational Affiliation
Kreiskrankenhaus Dormagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kreiskrankenhaus Dormagen
City
Dormagen
ZIP/Postal Code
D-51375
Country
Germany

12. IPD Sharing Statement

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Influence of Analgesia and Neuromuscular Block on Abdominal Distension and Operating Conditions Laparoscopic Operations

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